U.S. patent application number 14/416714 was filed with the patent office on 2015-07-16 for indwelling urinary catheter.
The applicant listed for this patent is ADVANCEATH LLC, UNIVERSITY OF UTAH RESEARCH FOUNDATION. Invention is credited to Nicholas Ray Blickenstaff, William O. Brant, Christopher Noel Cindrich, Garrett Curtis Coman, Ryan James O'Callaghan.
Application Number | 20150196730 14/416714 |
Document ID | / |
Family ID | 49997744 |
Filed Date | 2015-07-16 |
United States Patent
Application |
20150196730 |
Kind Code |
A1 |
O'Callaghan; Ryan James ; et
al. |
July 16, 2015 |
INDWELLING URINARY CATHETER
Abstract
A urinary catheter generally includes a core lumen, a bladder
retention mechanism, and a stent. The core lumen is insertable into
a urethra, and defines an inlet end and an outlet end opposite the
inlet end. The bladder retention mechanism is coupled to the inlet
end of the core lumen for hingedly moving between a release
position and a retention position. The stent is coaxially mounted
on the core lumen adjacent the bladder retention mechanism, and
defines a stent inlet configured to receive a fluid from the
bladder, and a stent outlet configured to discharge the fluid
around the core lumen and into the urethra.
Inventors: |
O'Callaghan; Ryan James;
(Cottonwood Heights, UT) ; Coman; Garrett Curtis;
(Salt Lake City, UT) ; Brant; William O.; (Salt
Lake City, UT) ; Blickenstaff; Nicholas Ray; (Salt
Lake City, UT) ; Cindrich; Christopher Noel; (Draper,
UT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
UNIVERSITY OF UTAH RESEARCH FOUNDATION
ADVANCEATH LLC |
Salt Lake City
Cottonwood Heights |
UT
UT |
US
US |
|
|
Family ID: |
49997744 |
Appl. No.: |
14/416714 |
Filed: |
July 19, 2013 |
PCT Filed: |
July 19, 2013 |
PCT NO: |
PCT/US13/51206 |
371 Date: |
January 23, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61741561 |
Jul 23, 2012 |
|
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|
61782361 |
Mar 14, 2013 |
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Current U.S.
Class: |
604/544 |
Current CPC
Class: |
A61M 25/0017 20130101;
A61M 2025/0004 20130101; A61M 25/04 20130101 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61M 25/04 20060101 A61M025/04 |
Claims
1. A urinary catheter comprising: a core lumen insertable into a
urethra, the core lumen defining an inlet end and an outlet end
opposite the inlet end; a bladder retention mechanism coupled to
the inlet end of the core lumen for hingedly moving between a
release position and a retention position; a stent coaxially
mounted on the core lumen adjacent the bladder retention mechanism,
the stent defining a stent inlet configured to receive a fluid from
a bladder, and a stent outlet configured to discharge the fluid
around the core lumen and into the urethra.
2. The urinary catheter of claim 1, further comprising an outlet
sheath coupled to the outlet end of the core lumen, wherein the
outlet sheath is configured to receive the fluid, and wherein the
outlet sheath includes at least one conduit to discharge the
fluid.
3. The urinary catheter of claim 1, wherein the core lumen defines
a first outermost diameter, wherein the stent defines a second
outermost diameter, and wherein the second outermost diameter is
greater than the first outermost diameter.
4. The urinary catheter of claim 1, wherein the core lumen defines
a longitudinal axis, and wherein the bladder retention mechanism
includes a leg extending substantially parallel to the longitudinal
axis when the bladder retention mechanism is in the release
position.
5. The urinary catheter of claim 1, wherein the inlet end of the
core lumen is coupled to a plug, wherein the bladder retention
mechanism includes a socket formed therein, the socket having first
and second inner surfaces, the first inner surface being closer to
the outlet end of the core lumen than the second inner surface,
wherein the plug is insertable into the socket, and wherein the
plug abuts the second inner surface when the bladder retention
mechanism is in the release position.
6. The urinary catheter of claim 5, wherein a projection extends
from the plug toward the outlet end of the core lumen, wherein the
stent defines a reduced-diameter portion, and wherein the
projection is matingly receivable into the reduced-diameter
portion.
7. The urinary catheter of claim 1, wherein the core lumen defines
a longitudinal axis, and wherein the bladder retention mechanism
includes leg extending from the longitudinal axis when the bladder
retention mechanism is in the retention position.
8. The urinary catheter of claim 1, wherein the bladder retention
mechanism includes a socket formed therein, the socket having first
and second inner surfaces, the first inner surface being closer to
the outlet end than the second inner surface, wherein the inlet end
of the core lumen defines an abutment stop, and wherein the
abutment stop engages the first inner surface when the bladder
retention mechanism is in the retention position.
9. The urinary catheter of claim 8, wherein the bladder retention
mechanism includes a leg having a retention area in contact with
the bladder, and wherein moving the abutment stop toward the first
inner surface increases the retention area.
10. The urinary catheter of claim 8, wherein the inlet end of the
core lumen is coupled to a plug, and wherein the inlet end of the
core lumen is configured to be released from the plug when a
predetermined force is applied on the core lumen in a direction
from the inlet end toward the outlet end.
11. The urinary catheter of claim 1, wherein the outlet sheath
includes a first conduit and a second conduit branching from the
first conduit for removably coupling to a reservoir.
12. The urinary catheter of claim 11, wherein the first and second
conduits define an acute angle.
13. The urinary catheter of claim 1, wherein the outlet sheath is
coupled to a bellows to adjust a distance from the bladder
retention mechanism to the outlet end of the core lumen.
14. The urinary catheter of claim 1, further comprising a stent
sheath slidably coupled to the stent, the stent sheath extending
along a length so dimensioned as to be substantially flush with an
end portion of the urethra when the stent sheath is inserted into
the urethra.
15. The urinary catheter of claim 14, wherein the stent sheath is
dimensioned to matingly receive the stent.
16. A method for catheterization, the method comprising: advancing
a core lumen through a urethra of a patient into a bladder, wherein
the core lumen defines an inlet end and an outlet end opposite the
inlet end, wherein a bladder retention mechanism is coupled to the
inlet end in a release position, wherein a stent is coaxially
mounted on the core lumen adjacent the bladder retention mechanism,
and wherein the stent defines a stent inlet configured to receive a
fluid from the bladder, and a stent outlet configured to discharge
the fluid around the core lumen and into the urethra; and moving
the core lumen in a direction from the inlet end toward the outlet
end, whereupon the bladder retention mechanism hingedly moves from
the release position to a retention position.
17. The method of claim 16, further comprising coupling an outlet
sheath to the outlet end, wherein the outlet sheath is configured
to receive the fluid, and wherein the outlet sheath includes at
least one conduit to discharge the fluid.
18. The method of claim 16, wherein the outlet sheath includes a
first conduit and a second conduit branching from the first
conduit, wherein the method further comprises removably coupling a
reservoir of fluid to the first conduit, and injecting the fluid
into the first conduit.
19. The method of claim 16, wherein the core lumen defines a
longitudinal axis, wherein the bladder retention mechanism includes
a leg, and wherein moving the core lumen in a direction from the
inlet end toward the outlet end moves the leg from a position
substantially parallel to the longitudinal axis to a position
extending away from the longitudinal axis.
20. The method of claim 16, wherein the bladder retention mechanism
includes a leg having a retention area in contact with the bladder,
and wherein moving the core lumen in a direction from the inlet end
toward the outlet end moves increases the retention area.
21. The method of claim 16, wherein a stent sheath is slidably
coupled to the stent, and wherein the stent sheath is slidably
removed from the stent when the bladder joint is in the retention
position.
22. The method of claim 16, wherein the inlet end of the core lumen
is coupled to a plug, wherein the bladder retention mechanism
includes a socket formed therein, the socket having first and
second inner surfaces, the first inner surface being closer to the
outlet end than the second inner surface, wherein the plug is
insertable into the socket, and wherein the plug is positioned
closer to the second inner surface than the first inner surface
inner surface when the bladder retention mechanism is in the
retention position, and wherein the method further comprises
inserting a wire through the core lumen when the bladder retention
mechanism is in the retention position, and moving the plug to a
position abutting against the second inner surface, whereupon the
bladder retention mechanism returns to the release position.
23. A urinary catheter comprising: a core lumen insertable into a
urethra, the core lumen defining an inlet end and an outlet end
opposite the inlet end, the inlet end of the core lumen being
attached to a plug; a bladder retention mechanism for hingedly
moving between a release position and a retention position, the
bladder retention mechanism having a socket formed therein into
which the plug is fitted; and a stent coaxially mounted on the core
lumen adjacent the bladder retention mechanism, the stent defining
a stent inlet configured to receive a fluid from a bladder, and a
stent outlet configured to discharge the fluid around the core
lumen and into the urethra, wherein a pulling force applied to the
core lumen removes the plug from the socket such that the bladder
retention mechanism is in the release position.
24. The urinary catheter of claim 23, further comprising a fluid
channel in fluid communication with the inlet end of the core lumen
to provide one of fluid sampling and fluid injection to one of a
bladder and a urethra.
25. The urinary catheter of claim 24, wherein the fluid channel is
adjacent to one of the stent and the bladder retention mechanism.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. provisional
applications No. 61/741,561, filed Jul. 23, 2012, and No.
61/782,361, filed Mar. 14, 2013, each of which is incorporated
herein by reference in its entirety.
BACKGROUND
[0002] Catheter-associated urinary tract infection (UTI) is one of
the most common hospital-acquired infections (HAI) and has affected
450,000 patients and added approximately $450 million to annual
healthcare costs in the US in 2002 (as adjusted to 2007 value). An
estimated 13,000 of the patients die from their UTI each year.
Foley catheters are the standard of care for patients requiring
indwelling catheterization; however, just having an indwelling
Foley catheter for over six days may increase the likelihood of
developing a UTI from approximately 5 times to approximately 7
times. Two thirds of UTIs from urinary catheters potentially
develop when bacteria, usually from the digestive tract, stick to
the external surface of the Foley catheter, where there is no flow
of urine, presenting a warm, moist, stagnant space that is ideal
for biofilm growth. In addition to a risk of infection, Foley
catheters can be painful due to their large diameter and may put
patient safety at risk due to the large balloon that holds the
device in the bladder. Patients who are demented or coming off of
anesthesia may attempt to pull their catheter out, which can damage
the urethra and potentially require additional surgery to repair,
leading to additional costs and the potential for future health
problems.
[0003] In 2008, the Centers for Medicare and Medicaid Services
(CMS) announced that hospital-acquired UTI would no longer be
covered, meaning hospitals are responsible for the cost and must
focus on prevention rather than treatment of UTI. Additionally, in
2014, the 25% of hospitals with the highest rate of HAI will be
subject to a 1% Medicare reimbursement penalty, estimated to be
approximately $208 k per hospital. UTI rates are currently
published on medicare.gov for around 70% of hospitals and 96% of
nursing homes, and will be mandatory effective in 2014. Thus, there
has developed a need to decrease infection rates in patients with
indwelling urinary catheters.
SUMMARY
[0004] In one embodiment, the invention provides a urinary catheter
generally including a core lumen, a bladder retention mechanism,
and a stent. The core lumen is insertable into a urethra, and
defines an inlet end and an outlet end opposite the inlet end. The
bladder retention mechanism is coupled to the inlet end of the core
lumen for hingedly moving between a release position and a
retention position. The stent is coaxially mounted on the core
lumen adjacent the bladder retention mechanism, and defines a stent
inlet configured to receive a fluid from a bladder, and a stent
outlet configured to discharge the fluid around the core lumen and
into the urethra.
[0005] In another embodiment, the invention provides a method for
catheterization generally including advancing a core lumen through
a urethra of a patient into a bladder. The core lumen defines an
inlet end and an outlet end opposite the inlet end. A bladder
retention mechanism is coupled to the inlet end in a release
position. A stent is coaxially mounted on the core lumen adjacent
the bladder retention mechanism. The stent defines a stent inlet
configured to receive a fluid from the bladder, and a stent outlet
configured to discharge the fluid stream around the core lumen and
into the urethra. The core lumen is moved in a direction from the
inlet end toward the outlet end, whereupon the bladder retention
mechanism hingedly moves from the release position to a retention
position.
[0006] In still another embodiment, the invention provides a
urinary catheter. The urinary catheter includes a core lumen
insertable into a urethra, the core lumen defining an inlet end and
an outlet end opposite the inlet end, the inlet end of the core
lumen being attached to a plug; a bladder retention mechanism for
hingedly moving between a release position and a retention
position, the bladder retention mechanism having a socket formed
therein into which the plug is fitted; and a stent coaxially
mounted on the core lumen adjacent the bladder retention mechanism,
the stent defining a stent inlet configured to receive a fluid from
a bladder, and a stent outlet configured to discharge the fluid
around the core lumen and into the urethra, wherein a pulling force
applied to the core lumen removes the plug from the socket such
that the bladder retention mechanism is in the release
position.
[0007] Other aspects of the invention will become apparent by
consideration of the detailed description and accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a side view of a urinary catheter according to an
embodiment of the invention, including a core lumen, a bladder
retention mechanism, a stent, and an outlet sheath.
[0009] FIG. 2 is a side view of a urinary catheter according to
another embodiment of the invention.
[0010] FIG. 3 is an enlarged partial side view of the catheter of
FIG. 1.
[0011] FIG. 4 is side view similar to FIG. 1, illustrating the
bladder retention mechanism in a release position.
[0012] FIG. 5 is a sectional view taken along line V-V of FIG.
4.
[0013] FIG. 6 is an enlarged partial perspective view illustrating
the bladder retention mechanism in a retention position.
[0014] FIG. 7 is an enlarged partial cutaway view of the core
lumen, bladder retention mechanism, and stent of FIG. 1.
[0015] FIG. 8 is an enlarged partial sectional view of the urinary
catheter of FIG. 1, with the core lumen removed.
[0016] FIG. 9 is an enlarged partial perspective view of a bladder
retention mechanism according to another embodiment of the
invention.
[0017] FIG. 10 is an enlarged partial cutaway view of the bladder
retention mechanism of FIG. 1.
[0018] FIG. 11 is an enlarged sectional view of the outlet sheath
of FIG. 1, including a condom component coupled to a pair of
conduits.
[0019] FIG. 12 is a side view of the outlet sheath of FIG. 1,
illustrating the condom component removed from the pair of
conduits.
[0020] FIG. 13 is a sectional view of the urinary catheter of FIG.
1, illustrating a wire being inserted into a first conduit.
[0021] FIG. 14 is a cross-sectional view of the core lumen, bladder
retention mechanism, and stent according to an embodiment of a
urinary catheter.
[0022] FIG. 15 is a cross-sectional view of a portion of the
urinary catheter of FIG. 14.
[0023] FIG. 16 is a cross-sectional view of the core lumen, bladder
retention mechanism, and stent according to an embodiment of a
urinary catheter.
[0024] FIGS. 17A, 17B, and 17C are cross-sectional views of a
portion of the urinary catheter of FIG. 16.
[0025] FIG. 18 shows a urinary catheter prior to removal from a
patient's bladder.
[0026] FIG. 19 shows a cross-sectional view of a urinary catheter
with its bladder retention mechanism in a release position.
DETAILED DESCRIPTION
[0027] Before any embodiments of the invention are explained in
detail, it is to be understood that the invention is not limited in
its application to the details of construction and the arrangement
of components set forth in the following description or illustrated
in the following drawings. The invention is capable of other
embodiments and of being practiced or of being carried out in
various ways.
[0028] Referring to FIG. 1, a urinary catheter 100 includes a core
lumen 110, a bladder retention mechanism 120, and a stent 130. The
core lumen 110 is insertable into a urethra U, and defines an inlet
end 140 and an outlet end 150 opposite the inlet end 140. The
bladder retention mechanism 120 is coupled to the inlet end 140 of
the core lumen 110 for hingedly moving between a release position
(see FIGS. 3-5) and a retention position (see FIGS. 1,2, and 6-9).
The stent 130 is coaxially mounted on the core lumen 110 adjacent
the bladder retention mechanism 120, and defines a stent inlet 160
configured to receive a fluid (e.g., urine or a urinary stream
containing urine plus one or more other fluid) from a bladder B,
and a stent outlet 170 configured to discharge the fluid around the
core lumen 110 and into the urethra U. In the illustrated
embodiment, the stent 130 is positioned adjacent a prostate P, and
therefore is a prostatic stent. In other embodiments, other
prostheses or structures performing the same function as the
prostatic stent 130 disclosed herein can be used instead. In
particular, embodiments of the urinary catheter 100 may be adapted
for use with a female anatomy, which includes among other changes a
female counterpart (e.g., urethral sphincter stent) to the
prostatic stent (see FIG. 2). The urinary catheter 100 according to
this invention may be made of any physiologically-compatible
material having sufficient pliability and elasticity. Such
materials are known in the art and include, for example plastics
such as polyurethane.
[0029] In the illustrated embodiment, the core lumen 110 defines a
first outermost diameter D.sub.1, and the stent 130 defines a
second outermost diameter D.sub.2. The second outermost diameter
D.sub.2 is greater than the first outermost diameter D.sub.1. The
different outermost diameters D.sub.1, D.sub.2 can facilitate
discharging the fluid around the core lumen 110 and into the
urethra U, and also improve patient comfort. In some embodiments,
the second outermost diameter D.sub.2 is at least two times, at
least three times, at least four times, at least five times, or at
least ten times the first outermost diameter D.sub.1. In other
embodiments, the second outermost diameter D.sub.2 can be of
another ratio to the first outermost diameter D.sub.1.
[0030] In some embodiments, the first outermost diameter D1 is in a
range of about 1.5 mm to about 2.5 mm, and the second outermost
diameter D.sub.2 is in a range of about 5 mm to about 10 mm. This
includes the first outermost diameter D.sub.1 of at least 1.5 mm,
at least 1.6 mm, at least 1.7 mm, at least 1.8 mm, at least 1.9 mm,
at least 2.0 mm, at least 2.1 mm, at least 2.2 mm, at least 2.3 mm,
or at least 2.4 mm. In further embodiments, the first outermost
diameter D.sub.1 is no more than 2.5 mm, no more than 2.4 mm, no
more than 2.3 mm, no more than 2.2 mm, no more than 2.1 mm, no more
than 2.0 mm, no more than 1.9 mm, no more than 1.8 mm, no more than
1.7 mm, or no more than 1.6 mm. In other embodiments, the first
outermost diameter D.sub.1 may be of other dimensions.
[0031] In some embodiments, the second outermost diameter D.sub.2
is at least 5.0 mm, at least 5.1 mm, at least 5.2 mm, at least 5.3
mm, at least 5.4 mm, at least 5.5 mm, at least 5.6 mm, at least 5.7
mm, at least 5.8 mm, at least 5.9 mm, at least 6.0 mm, at least 6.1
mm, at least 6.2 mm, at least 6.3 mm, at least 6.4 mm, at least 6.5
mm, at least 6.6 mm, at least 6.7 mm, at least 6.8 mm, at least 6.9
mm, at least 7.0 mm, at least 7.1 mm, at least 7.2 mm, at least 7.3
mm, at least 7.4 mm, at least 7.5 mm, at least 7.6 mm, at least 7.7
mm, at least 7.8 mm, at least 7.9 mm, at least 8.0 mm, at least 8.1
mm, at least 8.2 mm, at least 8.3 mm, at least 8.4 mm, at least 8.5
mm, at least 8.6 mm, at least 8.7 mm, at least 8.8 mm, at least 8.9
mm, at least 9.0 mm, at least 9.1 mm, at least 9.2 mm, at least 9.3
mm, at least 9.4 mm, at least 9.5 mm, at least 9.6 mm, at least 9.7
mm, at least 9.8 mm, or at least 9.9 mm. In further embodiments,
the second outermost diameter D.sub.2 is no more than 10.0 mm, no
more than 9.9 mm, no more than 9.8 mm, no more than 9.7 mm, no more
than 9.6 mm, no more than 9.5 mm, no more than 9.4 mm, no more than
9.3 mm, no more than 9.2 mm, no more than 9.1 mm, no more than 9.0
mm, no more than 8.9 mm, no more than 8.8 mm, no more than 8.7 mm,
no more than 8.6 mm, no more than 8.5 mm, no more than 8.4 mm, no
more than 8.3 mm, no more than 8.2 mm, no more than 8.1 mm, no more
than 8.0 mm, no more than 7.9 mm, no more than 7.8 mm, no more than
7.7 mm, no more than 7.6 mm, no more than 7.5 mm, no more than 7.4
mm, no more than 7.3 mm, no more than 7.2 mm, no more than 7.1 mm,
no more than 7.0 mm, no more than 6.9 mm, no more than 6.8 mm, no
more than 6.7 mm, no more than 6.6 mm, no more than 6.5 mm, no more
than 6.4 mm, no more than 6.3 mm, no more than 6.2 mm, no more than
6.1 mm, no more than 6.0 mm, no more than 5.9 mm, no more than 5.8
mm, no more than 5.7 mm, no more than 5.6 mm, no more than 5.5 mm,
no more than 5.4 mm, no more than 5.3 mm, no more than 5.2 mm, or
no more than 5.1 mm. In other embodiments, the second outermost
diameter D.sub.2 may be of other dimensions.
[0032] In some embodiments, the first and second diameters D.sub.1,
D.sub.2 may be required to have a particular tolerance dependent on
the application. For example, one application may require a
tolerance of approximately .+-.0.01 mm, while another application
may allow a tolerance of approximately .+-.0.1 mm. In some
embodiments, one or both of the core lumen 110 and stent 130 may
have a cross-sectional shape other than circular (e.g. oval,
square, rectangular, or other regular or irregular shapes) in which
cases the outermost diameters as used herein may include dimensions
other than a diameter, for example the lengths of major axes or the
cross-sectional area of the core lumen 110 and stent 130.
[0033] In some embodiments, the stent 130 extends along a length
that is less than the entire length of the urethra U. For example,
the stent 130 may extend along a length from approximately 5 cm to
approximately 10 cm. The length of the stent 130 can facilitate
discharging urine through the urethra U, thereby flushing out
bacteria that may otherwise cause an infection. For example, a
urinary catheter that does not provide a continual flow of urine on
its external surface may present a warm, moist, and stagnant space
that can be ideal for biofilm growth. In contrast, the stent 130
extends along a length that is less than the entire length of the
urethra U, thereby allowing urine to flow externally to the core
lumen 110 and substantially eliminating the stagnant space. In this
regard, the shortened length of the stent 130 facilitates the use
of the body's natural mechanism of flushing the urethral wall to
prevent biofilm formation.
[0034] Referring also to FIG. 3, a stent sheath 180 is slidably
coupled to the stent 130. In some embodiments, the stent sheath 180
is dimensioned to matingly receive the stent 130. The stent sheath
180 can facilitate placing the urinary catheter 100. To place the
urinary catheter 100, a distal end 184 of the urinary catheter 100
(e.g., a Coude tip) is inserted into the meatus (not shown) with
the stent sheath 180 coupled to the stent 130. The distal end 184
is pushed through the urethra U until it reaches the bladder B,
which is signaled by urine flowing through the urinary catheter
100. Once the urine has drained, the core lumen 110 is pulled from
the outlet end 150 while holding an outside of the stent sheath
180. As explained below, this will activate the bladder retention
mechanism 120. A marking on the core lumen 110 may indicate that
the core lumen 110 has been pulled far enough in relation to the
stent sheath 180 to move the bladder retention mechanism 120 from
the release position to the retention position. The stent sheath
180 is then pulled or slid outwardly (i.e., downwardly in FIG. 3)
and removed from the urethra U.
[0035] In the illustrated embodiment, the bladder retention
mechanism 120 uses a Malecot type locking mechanism. The bladder
retention mechanism 120 includes four pairs of legs or wings 190,
which may be extending substantially straight when unencumbered,
due to material properties and/or the method of manufacturing.
Therefore, in some embodiments, the bladder retention mechanism 120
is configured to resiliently return to a substantially straight,
closed, or release position. In other embodiments, the bladder
retention mechanism 120 may be formed in other configurations. The
illustrated core lumen 110 defines a longitudinal axis 200, and if
the bladder retention mechanism 120 is divided into successive
imaginary quadrants about the longitudinal axis 200, each quadrant
has a respective pair of legs 190. Referring to FIG. 1, only two
pairs of legs 190 are shown on the bladder retention mechanism 120;
the remaining two pairs of legs 190 would be extending into and out
of the plane. Although the illustrated bladder retention mechanism
120 has four pairs of legs or wings 190, one or more legs 190 can
be provided, if desired. As illustrated in FIGS. 4 and 5, the legs
190 extend substantially parallel to and adjacent the longitudinal
axis 200 when the bladder retention mechanism 120 is in the release
position.
[0036] Referring also to FIG. 5, the inlet end 140 of the core
lumen 110 is coupled to a plug 210. The bladder retention mechanism
120 includes a socket or pocket 220 formed therein. The socket 220
has first and second inner surfaces 230, 240. The first inner
surface 230 is closer to the outlet end 150 of the core lumen 110
than the second inner surface 240. The plug 210 is insertable into
the socket 220, and abuts the second inner surface 240 when the
bladder retention mechanism 120 is in the release position.
[0037] In the illustrated embodiment, a projection 250 extends from
the plug 210 toward the outlet end 150 of the core lumen 110. The
projection 250 includes a tip or head portion 260 that has a larger
cross section relative to an adjacent body portion 270. The tip
portion 260 of the projection 250 resembles an arrowhead in cross
section, pointing toward the outlet end 150 of the core lumen 110
(i.e., downwardly in FIG. 5). That is, the cross section of the tip
portion 260 of the projection 250 tapers gradually in thickness in
a direction along the longitudinal axis 200 toward the outlet end
150 of the core lumen 110. The stent 130 defines an inner surface
with a reduced-diameter portion 280, and the tip portion 260 of the
projection 250 is matingly receivable into the reduced-diameter
portion 280 when the bladder retention mechanism 120 is in the
release position. That is, when the bladder retention mechanism 120
is in the release position, the tip portion 260 of the projection
250 rests on the reduced-diameter portion 280, and is prevented
from further moving toward the outlet end 150 of the core lumen
110. Other configurations are possible depending on the usage
requirements or preferences for the particular urinary catheter
100, including configurations where the tip portion 260 of the
projection 250 has a substantially uniform thickness in cross
section.
[0038] FIGS. 6-9 illustrate the urinary catheter 100 including the
bladder retention mechanism 120 in the retention position. In this
position, the legs 190 of the bladder retention mechanism 120
extend away or offset from the longitudinal axis 200. In some
embodiments, at least some of the legs 190 extend substantially
perpendicular to the longitudinal axis 200 when the bladder
retention mechanism 120 is in the retention position. In other
embodiments, the legs 190 can extend at a non-zero angle from the
longitudinal axis 200 when the bladder retention mechanism 120 is
in the retention position. Each leg 190 of the bladder retention
mechanism 120 defines a retention area in contact with the bladder
B, and moving the bladder retention mechanism 120 toward the
retention position increases the retention area, as explained
below.
[0039] The bladder retention mechanism 120 can be moved from the
release position to the retention position by moving the core lumen
110 in a direction from the inlet end 140 toward the outlet end
150. Referring to FIGS. 7 and 8, the illustrated plug 210 has a
first side 290 and a second side 300, the first side 290 being
closer to the first inner surface 230 than the second side 300. The
projection 250 defines an abutment stop 310 opposite the tip
portion 260, having an opening 320 formed therein for receiving the
plug 210. The plug 210 and abutment stop 310 are so dimensioned as
to give a substantially bulbous appearance when the first side 290
of the plug 210 is inserted into the opening 320. As the bladder
retention mechanism 120 is moved to the retention position, the
abutment stop 310 comes in contact with first inner surface 130,
thereby increasing friction against further movement (e.g., against
the legs 190 of the bladder retention mechanism 120 collapsing).
When the bladder retention mechanism 120 is fully moved to the
retention position, the abutment stop 310 engages the first inner
surface 130 and securely holds the legs 190 of the bladder
retention mechanism 120 in a fixed, desired orientation relative to
the longitudinal axis 200.
[0040] In some embodiments, once the bladder retention mechanism
120 is moved to the retention position, the bladder retention
mechanism 120 can remain in that position substantially without
requiring further user intervention or actuation. Once in the
retention position, the tip portion 260 of the projection 250
engages the reduced-diameter portion 280 of the stent 130 to keep
the bladder retention mechanism 120 in place. Therefore, the
bladder retention mechanism 120 will remain in the retention
position even if the core lumen 110 is subsequently disconnected
therefrom.
[0041] The illustrated body portion 270 of the projection 250 has a
cross section that is shaped and dimensioned to be retained in the
stent 130 by friction, e.g., by an interference fit in one
direction, while creating a slight gap or offset 330 in another
direction (e.g., substantially perpendicular to the direction
associated with the interference fit). In the illustrated
embodiment, the body portion 270 of the projection 250 has a
generally circular cross-sectional shape with one or more cutouts
or recesses extending parallel to the longitudinal axis 200 so that
the body portion 270 roughly resembles a paddle. In use, fluid
enters the gap 330 at the stent inlet 160 toward a first direction
334. The fluid then flows in a direction parallel to the
longitudinal axis 200 toward a second direction 336 (i.e.,
downwardly in FIG. 7). Subsequently, the fluid exits the stent 130
through the stent outlet 170 toward a third direction 338. In this
regard, the fluid flows substantially external to the body portion
270 of the projection 250.
[0042] FIG. 9 is an enlarged partial perspective view of a bladder
retention mechanism 400 according to another embodiment of the
invention. In this embodiment, the bladder retention mechanism 400
uses a Malecot type locking mechanism that includes a plurality of
legs or wings 410 that are not necessarily linear. The illustrated
legs 410 are joined at rounded or radiused corners with a
respective bending radius. The illustrated bladder retention
mechanism 400 hingedly moves from the release position to the
retention position by bending the legs 410 about an axis extending
substantially perpendicular to the longitudinal axis 200 or by
otherwise reducing the bending radius. As explained below, for
removal of the urinary catheter 100 from the urethra U, the bladder
retention mechanism 400 hingedly moves from the retention position
to the release position, by increasing the bending radius or by
otherwise increasing the bending radius.
[0043] Referring also to FIG. 10, the illustrated abutment stop 310
of the projection 250 is configured to be removed or released from
the plug 210 when a predetermined force is applied on the core
lumen 110 in a direction from the inlet end 140 toward the outlet
end 150. The plug 210 therefore stays in the socket 220, while the
abutment stop 310 of the projection 250 is allowed to be pulled out
toward the outlet end 150. The bladder retention mechanism 120 can
thus return to a substantially straight configuration (e.g., by way
of the resilience of the material) and be released from the bladder
B and subsequently from the urethra, if the patient accidentally or
intentionally applies an excessive force by pulling on the core
lumen 110, thereby preventing damage to the bladder B and/or the
urethra U.
[0044] Referring also to FIGS. 11 and 12, in the illustrated
embodiment, an outlet sheath 340 is coupled to the outlet end 150
of the core lumen 110. The illustrated outlet sheath 340 is
configured to receive fluid flowing from the stent outlet 170. In
the illustrated embodiment, the outlet sheath 340 includes a condom
component 350 coupled to first and second conduits 360, 370 to
discharge the fluid. In other embodiments, other structures
performing the same function as the condom component 350 disclosed
herein can be used instead. In particular, embodiments of the
urinary catheter 100 may be adapted for use with a female anatomy
(see, e.g., FIG. 2), which includes among other changes a female
counterpart to the outlet sheath and condom component such as the
illustrated cup or funnel 420.
[0045] In the illustrated embodiment, the first conduit 360 is
coupled to a first detachable coupler 380 such as a Tuohy-Borst
mechanism that can removably lock an external component (not shown)
to the first conduit 360. In use, any additional length of the core
lumen 110 extending out from the first detachable coupler 380 can
be cut or trimmed off, so that an end portion of the core lumen 110
is substantially flush with an end portion of the first detachable
coupler 380. The first conduit 360 can be connected via the
detachable coupler 380 to a reservoir of a saline solution, an
antimicrobial or antibacterial solution, or medication, to flush
the urethra U therewith, thereby inhibiting biofilm formation.
Referring also to FIGS. 7, and 10, the illustrated projection 250
includes a slit or channel 430 formed therein adjacent the stent
inlet 160. In some embodiments, the slit 430 is configured to open
upon an internal pressure for example applied by the antimicrobial
solution. In further embodiments, the slit 430 is configured to
resiliently close in absence of the internal pressure. Once the
slit 430 is closed, the fluid in the bladder B may present a force
that tend to open the slit 430. However, the slit 430 may be
configured to withstand this opening force by way of the resilience
of the material surrounding the slit 430. Thus, once the slit 430
is closed, the flow or leakage of the fluid through the slit 430
may be substantially prevented despite the pressure of the fluid in
the bladder B. In this regard, the slit 430 can act as a valve. In
other embodiments, the slit 430 may stay open at all times;
however, the surface tension of the fluid in the bladder B may
operate to effectively seal or block the slit 430 in absence of the
internal pressure. In still other embodiments, the slit 430 may be
configured to allow for fluid to flow from the bladder B through
the core lumen 110 when a negative pressure is applied therein, for
example by a syringe to sample urine from the bladder B.
[0046] The detachable coupler 380 can allow for changing the outlet
sheath 340 and/or external components, depending on the usage
requirements or preferences for the particular urinary catheter
100. The coupler 380 has an O-ring 440 that is squeezed inwardly
and tightened around the core lumen 110 when the first conduit 360
and the first detachable coupler 380 are coupled together. A second
detachable coupler 450 distal to the first detachable coupler 380
could also be a Tuohy-Borst coupler or a Luer-Lock for attaching a
syringe (not shown). For example, a syringe can be attached to the
second detachable coupler 450 for instilling a saline or
antimicrobial solution or drug through the core lumen 110 and out
the slit 430 to the bladder B and urethra U. Moreover, when
attached to the second detachable coupler 450, the syringe can
withdraw or sample a desired volume of urine the bladder B to
examine a bacterial load.
[0047] The second conduit 370 branches from the first conduit 360
for removably coupling to a reservoir or collection container (not
shown). For example, the second conduit 370 can be attached to a
collection container on the patient's leg or bedside. In the
illustrated embodiment, the first and second conduits 360, 370
define an acute angle. In other embodiments, the second conduit 370
can extend at a non-zero angle relative to the first conduit
360.
[0048] In some embodiments, the outlet sheath 340 is coupled to a
bellows or accordion adaptor (not shown) to adjust a distance from
the bladder retention mechanism 120 to the outlet end 150 of the
core lumen 110. Therefore, the outlet sheath 340 is allowed to be
adjusted for different urethral lengths. In some embodiments, the
bellows or accordion adaptor can be omitted.
[0049] Referring to FIG. 13, to remove the urinary catheter 100
from the urethra U, a wire 390 can be inserted through the core
lumen 110. The wire 390 is moved or threaded toward the inlet end
140 (i.e., upwardly in FIG. 13) until it comes in contact with the
plug 210. Once the wire 390 is in contact with the plug 210, the
plug 210 can be pushed toward the second inner surface 240,
whereupon the plug 210 separates from the abutment stop 310. As the
plug 210 continues to be pushed away from the abutment stop 310
against the second inner surface 240, the plug 120 is released or
removed from the abutment stop 310, thereby allowing the abutment
stop 310 to be released from the socket 220. The bladder retention
mechanism 120 then hingedly returns to the substantially
straightened release position. Once the bladder retention mechanism
120 is returned to the release position, the urinary catheter 100
can be safely pulled through the urethra U.
[0050] FIGS. 14-19 show additional embodiments of the urinary
catheter 100 in which numerical references are used as above unless
otherwise indicated. In the embodiment of FIG. 14, a plug 510 fits
into the socket 220, abutting the second inner surface 240, to
maintain the bladder retention mechanism 120 in the retention
position, as discussed above. The plug 510 includes a projection
550 which extends away from the plug 510 towards the outlet end 150
of the core lumen 110 (e.g. downwardly in FIG. 14). The surface
joining the plug 510 to the projection 550 may include a tapered or
curved surface 520 which abuts the first inner surface 230 of the
bladder retention mechanism 120.
[0051] The projection 550 includes a tip or head portion 560 which
has a larger cross section relative to an adjacent body portion
570. The tip portion 560 of the projection 550 resembles an
arrowhead in cross section, as described above. In this embodiment
the core lumen 110 is attached to a distal end of the tip portion
560 (e.g. by suitable adhesive and/or friction fit) such that a
pulling force exerted on the core lumen 110 is transferred to the
plug 510 via the projection 550.
[0052] In the embodiment of FIG. 14, the plug 510 is retained by a
neck 540 of the bladder retention mechanism 120. When a suitable
pulling force is applied to the core lumen 110, the plug 510 is
pulled and squeezes through the neck 540, thereby placing the
bladder retention mechanism 120 in the release position. As
discussed above, being in the release position permits the legs 190
to straighten towards the longitudinal axis 200, allowing the
catheter 100 to be removed from the bladder. In some embodiments,
the plug 510 is relatively rigid and the neck 540 is resilient so
that when the pulling force is applied the neck 540 stretches to
allow the plug 510 to move through. In other embodiments, the plug
510 is relatively resilient and the neck 540 is relatively rigid so
that when the pulling force is applied the plug 510 deforms to move
through the neck 540. In still other embodiments, the plug 510 and
the neck 540 each have varying levels of resilience through which
each deforms to a sufficient degree to permit the plug 510 to move
through the neck 540 when a pulling force is applied. Furthermore,
the properties of the plug 510 and neck 540 are such that the plug
510 is retained in the neck 540 during normal use.
[0053] FIGS. 14 and 15 show an embodiment of the urinary catheter
100 in which urine may be sampled from the bladder B or urethra U
or a material (e.g. antimicrobial solution or drug) may be
introduced into the bladder B or urethra U at a location near the
tip portion 560 of the extension 550 of the plug 510. FIG. 15 shows
a cross-section of the region where the end of the core lumen 110
is joined to the tip portion 560. As shown in FIG. 15, the tip
portion 560 is joined to the core lumen 110 by a cylindrical
extension 565 which terminates in an opening 530 through which
fluid can flow 544 in either direction. Thus, fluid may be
introduced or sampled through opening 530 by application of
positive or negative pressure through the core lumen 110.
[0054] FIGS. 16, 17A, 17B, and 17C show cross-sectional views of
another embodiment of the urinary catheter 100. A plug 610 fits
into the socket 220, abutting the second inner surface 240, to
maintain the bladder retention mechanism 120 in the retention
position, as discussed above. The plug 610 includes a projection
650 which extends away from the plug 610 towards the outlet end 150
of the core lumen 110 (e.g. downwardly in FIG. 16). The surface
joining the plug 610 to the projection 650 may include a tapered or
curved surface 620 which abuts the first inner surface 230 of the
bladder retention mechanism 120. The plug 610 is retained by a neck
640 of the bladder retention mechanism 120. As discussed above with
regard to FIG. 14, the plug 610 and neck 640 each have a level of
rigidity and/or resilience which permits the plug 610 to be pulled
through the neck 640 when a sufficient pulling force is applied to
the projection 650. The projection 650 terminates in a hollow
cylindrical opening into which the core lumen 110 is inserted and
attached (e.g. using suitable adhesive and/or friction fit), such
that a pulling force that is applied to the core lumen 110 is
transferred to the projection 650 and in turn to the plug 610.
Unlike the embodiment shown in FIG. 15, in the embodiment of FIG.
16 the tip portion 660 is not an extension of the projection 650
and instead is a separate element that is attached (e.g. with
adhesive and/or friction fitting) to the core lumen 110.
[0055] The embodiment of FIGS. 16, 17A, 17B, and 17C show an
embodiment of the urinary catheter 100 in which urine may be
sampled from the bladder B or a material (e.g. antimicrobial
solution or drug) may be introduced into the bladder B at a
location adjacent to the neck 640 of the bladder retention
mechanism 120. FIGS. 17A, 17B, and 17C show cross-sectional views
of the region where the end of the core lumen 110 is joined to the
projection 650. The core lumen 110 is aligned with a portion of the
projection 650 which includes a fluid channel and one or more
lateral openings 630 which permit fluid to flow 644 between the
core lumen 110 and the bladder B. The one or more lateral openings
630 open to a space below the neck 640 (as seen in FIGS. 16, 17A,
17B, and 17C) in which there is a gap between the projection 650
and the bladder retention mechanism 120. Thus, fluid may be
introduced or sampled through the one or more openings 630 by
application of positive or negative pressure through the core lumen
110.
[0056] FIGS. 18 and 19 show steps involved in removal of the
urinary catheter from a patient's bladder. After external
components other than the core lumen 110 have been removed, a stent
sheath 700 is slid over the core lumen until it abuts the end of
the stent 130. In various embodiments, the stent sheath 700 is
configured to have a contacting surface that is complementary to
that of the end of the stent 130. Holding the stent 130 steady
using the stent sheath 700, a pulling force is applied to the core
lumen 110, which in turn pulls the plug 510/610 through the neck
540/640. Once the plug 510/610 has been pulled clear of the neck
540/640, the legs 190/400 of the bladder retention mechanism 120
retract towards one another so that the bladder retention mechanism
120 assumes a narrower profile suitable for removal from the
bladder B.
[0057] Element 280 of the stent 130 is referred to herein as a
"reduced-diameter portion 280" simply for convenience; those of
skill in the art will understand that, in view of the tapered
nature of this portion, some regions of element 280 may also have
an increased diameter, depending on which features of the stent 130
element 280 is compared to. Furthermore, one skilled in the art
will also understand that, when the bladder retention mechanism 120
is in the release position, the tip portion 260/560/660 rests on
the reduced-diameter portion 280, and is prevented from further
moving toward either the outlet end 150 or the inlet end 140 of the
core lumen 110.
[0058] Thus, the invention provides, among other things, a urinary
catheter including a core lumen, a bladder retention mechanism, and
a stent, wherein the bladder retention mechanism hingedly moves
between a release position and a retention position, and wherein
the stent is configured to discharge fluid around the core lumen
and into the urethra. Various features and advantages of the
invention are set forth in the following claims.
* * * * *